Meshed Vein Graft Patency Trial - VEST | NCT01860274

Studies
Meshed Vein Graft Patency Trial - VEST

NCT01860274

Sponsor

Cardiochirurgia E.H.

Status

Completed

Last Update Posted

Mar 12, 2021Actual

Enrollment

102Actual

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

External Mesh for vein grafts

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 6, 2015Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Jun 28, 2020Actual

First Submitted Date

May 20, 2013

First Submission Date that Met QC Criteria

May 21, 2013

First Posted Date

May 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2021

Last Update Posted Date

Mar 12, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study hypothesis is that a meshed conduit made of safen vein allows a better patency at mid-long term than a safen vein alone.

To test this hypothesis the investigators plan a prospective, randomized study, comparing grafts to the diagonal, in cases of vessel diameter under 1.5mm. A control angiography will be performed one year after the operation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Label	Type	Description	Intervention Names
External Mesh	Experimental		Device: External Mesh for vein grafts

Name	Type	Description	Arm Group Labels	Other Names
External Mesh for vein grafts	Device		External Mesh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patency	Patency of graft at CT Scan	6 to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Major Adverse Cardiac and Cerebrovascular Events (MACCE)		60 months
Vein graft lumen uniformity		6 to 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical Indication for elective Coronary Artery Bypass Grafting with at least one vein graft
Coronary artery with critical stenosis (over 70%)

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luca Weltert, MD	European Hospital - Rome	Principal Investigator
Ruggero De Paulis, MD	European Hospital - Rome	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
European Hospital		Rome		00149	Italy
Mauriziano Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33845865	Derived	Weltert LP, Audisio K, Bellisaro A, Bardi G, Flocco R, De Paulis R, Centofanti P. External stenting of vein grafts in coronary artery bypass grating: interim results from a two centers prospective study. J Cardiothorac Surg. 2021 Apr 12;16(1):74. doi: 10.1186/s13019-021-01406-0.

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases